7 results
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17ms
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Sources: EU EUDAMED, US FDA
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FC-100 FEMORAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GAS
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 26, 2014
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·December 28, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015